CN116392460A - Salbutamol aerosol - Google Patents

Salbutamol aerosol Download PDF

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CN116392460A
CN116392460A CN202310415618.3A CN202310415618A CN116392460A CN 116392460 A CN116392460 A CN 116392460A CN 202310415618 A CN202310415618 A CN 202310415618A CN 116392460 A CN116392460 A CN 116392460A
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salbutamol
aerosol
pharmaceutically acceptable
acceptable salt
vitamin
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孙迎基
郑效全
孙利民
郑祥伟
张路
李铁军
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Jewim Pharmaceutical Shandong Co ltd
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/13—Amines
    • A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A61K31/137—Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/007—Pulmonary tract; Aromatherapy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/10—Dispersions; Emulsions
    • A61K9/12—Aerosols; Foams
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A61P11/06—Antiasthmatics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A61P11/08—Bronchodilators
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/10—Dispersions; Emulsions
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

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Abstract

The invention belongs to the technical field of pharmaceutical preparations, and provides an salbutamol aerosol which comprises salbutamol or pharmaceutically acceptable salt thereof, vitamin E succinic acid polyethylene glycol ester and a propellant. The salbutamol aerosol provided by the invention has good physical stability, and realizes good delivery dose uniformity and stable effective part deposition rate (FPF).

Description

Salbutamol aerosol
Technical Field
The invention belongs to the technical field of pharmaceutical preparations, and particularly relates to an albuterol aerosol.
Background
The bronchodilator can obviously relieve dyspnea caused by airway obstructive diseases such as bronchial asthma, chronic tracheitis and the like, and the drugs for dilating the bronchus mainly comprise beta 2 adrenergic receptor agonists and anticholinergic agents.
Salbutamol is a short-acting beta 2 adrenergic receptor agonist, has bronchodilatory effect and quick action, and is a classical emergency medicine for acute asthma attack. The salbutamol has two isomers of levorotatory body and dextrorotatory body, the main effect of which is that of levorotatory body, and the salbutamol raceme and levorotatory body are used as the products on the market at present.
Salbutamol is insoluble in the propellant and needs to be prepared into suspension type aerosol. Suspension aerosols, which have physical stability problems of the suspension, such as aggregation, sedimentation or floating of the drug particles, require that the product be shaken thoroughly to ensure uniform dispersion of the drug before the suspension aerosol is used, and that the drug be delivered immediately after shaking to ensure that the delivered dose contains an effective concentration of the drug active ingredient, which has high patient handling requirements, reduced patient compliance, and an impact on the therapeutic efficacy of the disease.
Salbutamol is a drug for effectively treating asthma acute attacks, and development of suspension type aerosols with good physical stability is urgently needed clinically. Chinese patent document CN 103857388B discloses a method for improving the physical stability of albuterol aerosol. The propellant difluoroethane (152 a) is used in the prescription, but the propellant 152a has combustibility and low safety, the existing production equipment cannot meet the commercial production of aerosol taking 152a as the propellant, and no aerosol taking 152a as the propellant is marketed up to the present.
The vitamin E polyethylene glycol succinate (VETPGS) is used in the composition, tetrafluoroethane or heptafluoropropane is used as a propellant, and the prepared aerosol suspension is unexpectedly found to have good physical stability, and can still keep good medicine uniformity after being placed for 120 seconds after shaking.
Disclosure of Invention
Aiming at the defects of the prior art, the invention unexpectedly discovers that the vitamin E polyethylene glycol succinate (VETPGS) can obviously improve the physical stability of the salbutamol suspension aerosol. The object of the present invention is to provide a suspension aerosol comprising albuterol or a pharmaceutically acceptable salt thereof.
The aim of the invention is achieved by the following technical scheme.
The invention provides an albuterol suspension aerosol, which comprises albuterol or pharmaceutically acceptable salt thereof, vitamin E succinic acid polyethylene glycol ester and a propellant.
The vitamin E succinic acid polyethylene glycol ester (VETPGS) is selected from one or more of VETPGS200, VETPGS400, VETPGS1000, VETPGS1500, VETPGS2000 and VETPGS 4000.
The mass ratio of the vitamin E succinic acid polyethylene glycol ester to the salbutamol or the pharmaceutically acceptable salt thereof is 1:17.45-1:1.45, preferably 1:8.73-1:1.45.
The salbutamol aerosol also comprises ethanol. The ethanol can promote the dissolution of the vitamin E succinic acid polyethylene glycol ester in the propellant. Preferably, the ethanol content is 3% -10% (w/w).
The salbutamol is salbutamol racemate and levorotatory, and the pharmaceutically acceptable salt is salbutamol sulfate or levorotatory salbutamol tartrate, and most preferably salbutamol sulfate.
The propellant is selected from tetrafluoroethane (HFA 134 a) and/or heptafluoropropane (HFA 227).
According to a specific technical scheme, the salbutamol aerosol comprises the following components in parts by weight: 1.7 parts of salbutamol or pharmaceutically acceptable salt thereof, 0.1 to 1.2 parts of vitamin E succinic acid polyethylene glycol ester, 30 to 100 parts of ethanol and 1000 parts of propellant.
According to a preferred embodiment of the present invention, the particle size D90 of the salbutamol or the pharmaceutically acceptable salt thereof is 4.3-6.7 μm, and the particle size D50 is 1.5-3.3 μm.
The invention has the advantages that:
the suspension salbutamol aerosol prepared by the invention has good physical stability, can keep good suspension uniformity after long-time placement, and realizes good delivery dose uniformity and stable effective part deposition rate (FPF, namely the mass percent of aerosol drug particles with the aerodynamic particle size smaller than 5 mu m).
Drawings
FIG. 1 is a graph of particle size according to example 23 of the present invention.
Detailed Description
The following examples illustrate the specific steps of the present invention, but are not limited thereto. The terms used in the present invention generally have meanings commonly understood by those of ordinary skill in the art unless otherwise indicated. The invention will be described in further detail below in connection with specific examples and with reference to the data. It should be understood that these examples are intended to illustrate the invention and are not intended to limit the scope of the invention in any way.
In the following examples, various processes and methods, which are not described in detail, are conventional methods well known in the art.
Examples 1-4 preparation of salbutamol sulphate aerosol samples (without stabilizer)
Prescription:
Figure BDA0004184888380000021
Figure BDA0004184888380000031
the preparation method comprises the following steps:
1. salbutamol sulfate particles (D50:3.3 μm; D90:6.7 μm) were added to a preparation tank, and anhydrous ethanol and heptafluoropropane were added and mixed to prepare a suspension.
2. Sealing the aluminum pot and the quantitative valve (50 μl valve is taken as an example), and filling the suspension liquid medicine to obtain the aerosol product.
Quality study:
delivery Dose Uniformity (DDU): the delivery dose uniformity measurement method of the inhalation aerosol under the inhalation formulation item of the four general rules 0111 of the edition 2020 of Chinese pharmacopoeia is adopted for detection, and at least 9 of the 10 data required to be measured are within 75-125% of the average value and all are within 65-135% of the average value.
Content of single press: taking a sample, shaking the sample fully, standing the sample for a certain time, detecting the sample by adopting a delivery dose uniformity measuring device of the inhalation aerosol under the inhalation preparation item of the four general rules 0111 of the Chinese pharmacopoeia 2020 edition, collecting 5 presses, and calculating the average value of the 5 presses, namely the single press content.
TABLE 1
Figure BDA0004184888380000032
From the above table, it is known that: the product without ethanol in the prescription has poor uniformity of delivery dosage and does not meet the standard requirement. The addition of ethanol to the formulation improves the uniformity of the delivered dose, but the single press content is significantly increased with the prolonged placement time, and the suspension performance of the liquid medicine is poor. Examples 5-12 preparation of salbutamol sulphate aerosol samples (different stabilisers)
Prescription:
Figure BDA0004184888380000041
the preparation method comprises the following steps:
1. salbutamol sulfate particles (D50: 3.3 μm; D90:6.7 μm) and adjuvants are added into a preparation tank, anhydrous ethanol and heptafluoropropane are added, and mixed to obtain suspension liquid.
2. Sealing the aluminum pot and the quantitative valve (50 μl valve is taken as an example), and filling the suspension liquid medicine to obtain the aerosol product.
Quality study:
(1) The aerosol product was subjected to single press content studies of delivered dose uniformity and after shaking, standing for different times, the test method was the same as in example 1, and the test results were as follows:
TABLE 2
Figure BDA0004184888380000042
Figure BDA0004184888380000051
From the above table, it is known that: the delivery dosage containing the VETPGS prescription has good uniformity, and the liquid medicine still has good suspension performance after standing for a period of time after shaking.
(2) Effective fraction deposition (FPF) studies on aerosol products
The detection method comprises the following steps: according to the measurement method of four 0951 inhalation preparation micro-fine particles aerodynamic characteristics of Chinese pharmacopoeia 2020 edition, the measurement is carried out by a device 2 (Anderson cascade impactor, ACI) under the general rule, the ACI device is connected in sequence, and the gas flow rate is regulated to enable the gas flow rate at the inlet of the L-shaped connecting pipe to reach 28.3L/min (+ -5%). Taking 1 pot of the product, shaking for 5 seconds, and discarding a plurality of presses according to the specification of the product. Inserting the suction device into the suction nozzle adapter, shooting for 1 time, pumping for 5 seconds, repeating the above process to collect 5 shots, waiting for 30 seconds after the last shot, taking down the sample, closing the vacuum pump, and dismantling the device. The ACI levels were rinsed with appropriate solvents, the levels were checked by HPLC, and FPF was calculated.
TABLE 3 Table 3
Figure BDA0004184888380000052
Figure BDA0004184888380000061
Examples 5 to 9 show that FPFs containing Tween 80 or oleic acid or polyoxyethylene lauryl ether (benzzel 30) or span 20 or poloxamer formulations have a significant decrease in the course of placement, whereas FPFs containing VETPGS formulations have no significant decrease in the course of placement, indicating that VETPGS can stabilize the drug particle suspension properties (examples 10 to 12).
Examples 13 to 17 preparation of salbutamol sulphate aerosol samples (different amounts of VETPGS 1000)
Prescription:
Figure BDA0004184888380000062
the preparation method comprises the following steps:
1. salbutamol sulfate particles (D50: 3.3 μm; D90:6.7 μm) and adjuvants are added into a preparation tank, anhydrous ethanol and heptafluoropropane are added, and mixed to obtain suspension liquid.
2. Sealing the aluminum pot and the quantitative valve (50 μl valve is taken as an example), and filling the suspension liquid medicine to obtain the aerosol product.
Quality study:
(1) The aerosol product was subjected to single press content studies of delivered dose uniformity and standing for different times after shaking, the test method was the same as in example 1, and the test results were as follows:
TABLE 4 Table 4
Figure BDA0004184888380000063
Figure BDA0004184888380000071
From the above table, it is known that: the dosage of the VETPGS1000 is in the range of 0.01-0.12% w/w (corresponding to the mass ratio of salbutamol sulfate to VETPGS1000 being 1:17.45-1:1.45), the uniformity of the delivery dosage is good, the single-press content is detected to have no obvious trend of rising after shaking for different times, and the dosage is more preferably in the range of 0.02-0.12% w/w (corresponding to the mass ratio of salbutamol sulfate to VETPGS1000 being 1:8.73-1:1.45).
(2) The aerosol product was subjected to an effective fraction deposition rate (FPF) study and was measured according to the four 0951 inhalation formulation fine particle aerodynamic properties assay rule under the following device 2 (Anderson cascade impactor, ACI) of the chinese pharmacopoeia 2020 edition, with the following results:
TABLE 5
Figure BDA0004184888380000081
From the above table, it is known that: the dosage of the VETPGS1000 is in the range of 0.01-0.12% w/w (which is equivalent to the mass ratio of salbutamol sulfate to the VETPGS1000 of 1:17.45-1.45), the FPF is more than 40%, and the FPF has no obvious descending trend in the placing process.
Examples 18 to 21 preparation of salbutamol sulphate aerosol samples (different ethanol amounts)
Prescription:
Figure BDA0004184888380000082
the preparation method comprises the following steps:
1. salbutamol sulfate particles (D50: 3.3 μm; D90:6.7 μm) and adjuvants are added into a preparation tank, anhydrous ethanol and heptafluoropropane are added, and mixed to obtain suspension liquid.
2. Sealing the aluminum pot and the quantitative valve (50 μl valve is taken as an example), and filling the suspension liquid medicine to obtain the aerosol product.
Quality study: the aerosol product was subjected to single press content studies of delivered dose uniformity and standing for different times after shaking, the test method was the same as in example 1, and the test results were as follows:
TABLE 6
Figure BDA0004184888380000083
Figure BDA0004184888380000091
From the above table, it is known that: the ethanol dosage is in the range of 3-10% w/w, the uniformity of the delivered dose is good, and the single-press content is detected to have no obvious tendency to rise after shaking and different times of standing, so that the suspension performance of the drug suspension is not influenced.
Examples 22-24 preparation of salbutamol sulphate aerosol samples (different raw material particle sizes)
Prescription:
Figure BDA0004184888380000092
the preparation method comprises the following steps:
1. adding salbutamol sulfate particles and auxiliary materials into a preparation tank, adding propellant heptafluoropropane, and mixing to prepare suspension liquid medicine.
2. Sealing the aluminum pot and the quantitative valve (50 μl valve is taken as an example), and filling the suspension liquid medicine to obtain the aerosol product.
Quality study: the aerosol product was subjected to an effective fraction deposition rate (FPF) study and was measured by the following device 2 (Anderson cascade impactor, ACI) according to the four 0951 inhalation formulation fine particle aerodynamic properties assay rule of the chinese pharmacopoeia 2020 edition, with the following results:
TABLE 7
Figure BDA0004184888380000093
As is evident from the above, the FPF of the product prepared in example 22 and example 23 was greater than 40% and the particle size was selected from the group consisting of D90 particle size of 4.3 to 6.7. Mu.m, and D50 particle size of 1.5 to 3.3. Mu.m. The particle size spectrum of example 23 is shown in figure 1.
EXAMPLE 25 stability investigation
The sample prepared in example 23 was examined for accelerated stability (temperature 40 ℃ ± 2 ℃/humidity 75% ± 5%), and the delivered dose uniformity, FPF and related substances were examined with good results, and the single press content was examined after shaking for different times without significant trend of rise, as follows:
TABLE 8
Figure BDA0004184888380000101
The above examples illustrate only a few embodiments of the present invention, which are described in detail and are not to be construed as limiting the scope of the invention, and it should be noted that modifications and improvements can be made by those skilled in the art without departing from the spirit of the invention, which are within the scope of the invention. Accordingly, the scope of protection of the present invention is to be determined by the appended claims.

Claims (10)

1. An aerosol of salbutamol, which is characterized by comprising salbutamol or pharmaceutically acceptable salt thereof, vitamin E succinic acid polyethylene glycol ester and a propellant.
2. Salbutamol aerosol formulation according to claim 1, characterized in that the vitamin E polyethylene glycol succinate is selected from one or several of the group consisting of VETPGS200, VETPGS400, VETPGS1000, VETPGS1500, VETPGS2000, VETPGS 4000.
3. Salbutamol aerosol according to claim 1, wherein the mass ratio of vitamin E polyethylene glycol succinate to salbutamol or a pharmaceutically acceptable salt thereof is 1:17.45-1:1.45.
4. An aerosol salbutamol according to claim 3 wherein the mass ratio of vitamin E polyethylene glycol succinate to salbutamol or a pharmaceutically acceptable salt thereof is from 1:8.73 to 1:1.45.
5. Salbutamol aerosol according to claim 3, characterized in that it also comprises ethanol.
6. Salbutamol aerosol according to claim 5, characterized in that the ethanol content is 3% -10%, w/w.
7. Salbutamol aerosol according to claim 1, characterized in that the propellant is selected from tetrafluoroethane and/or heptafluoropropane.
8. Salbutamol aerosol according to claim 1, wherein the salbutamol is the salbutamol racemate or the levorotatory form and the pharmaceutically acceptable salt of salbutamol is salbutamol sulphate or levorotatory salbutamol tartrate.
9. Salbutamol aerosol according to claim 6, characterized in that the salbutamol aerosol comprises the following components in parts by weight: 1.7 parts of salbutamol or pharmaceutically acceptable salt thereof, 0.1 to 1.2 parts of vitamin E succinic acid polyethylene glycol ester, 30 to 100 parts of ethanol and 1000 parts of propellant.
10. Salbutamol aerosol according to any of claims 1 to 9, wherein the salbutamol or a pharmaceutically acceptable salt thereof has a particle size D90 of from 4.3 to 6.7 μm and a D50 of from 1.5 to 3.3 μm.
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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2000045795A2 (en) * 1999-02-05 2000-08-10 Cipla Limited Topical sprays comprising a film forming composition
CN103520106A (en) * 2012-07-02 2014-01-22 江苏山信药业有限公司 Salbutamol sulphate inhalation aerosol and preparation method thereof
CN110585177A (en) * 2019-10-17 2019-12-20 广东同德药业有限公司 Salbutamol sulfate inhalation aerosol and preparation process thereof

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2000045795A2 (en) * 1999-02-05 2000-08-10 Cipla Limited Topical sprays comprising a film forming composition
CN103520106A (en) * 2012-07-02 2014-01-22 江苏山信药业有限公司 Salbutamol sulphate inhalation aerosol and preparation method thereof
CN110585177A (en) * 2019-10-17 2019-12-20 广东同德药业有限公司 Salbutamol sulfate inhalation aerosol and preparation process thereof

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
张雯等: "含有新型抛射剂的硫酸沙丁胺醇气雾剂的制备", 《齐鲁药事》, vol. 31, no. 7, pages 377 - 378 *
郑楠楠等: "聚乙二醇维生素E琥珀酸酯在药剂学中的应用进展", 《中国药学杂志》, vol. 49, no. 16, pages 1373 - 1376 *

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